Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

Stroke Clinical Trial

Official title:

Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016119
• Other study ID #: CAT-0915-CU
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2009
• Last updated: March 4, 2010
• Start date: October 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate whether Folrex, could improve the motor recovery of the upper extremity after stroke in comparison with placebo during 4 weeks of treatment.

Description:

Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month. Each value will be compare to evaluate whether the groups of patient improve.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with acute stroke < 24 hours.

• Patients with impairment up to 4 on NIHSS scale.

• Family support.

• Informed consent.

Exclusion Criteria:

• Presence of another disease not well controlled.

• Patient with dementia.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Folrex
Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
• Placebo
Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation

Locations

Country	Name	City	State
Cuba	Salvador Allende Hospital	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month (4 weeks).		4 weeks	Yes
Secondary	Barthel index		4 weeks	Yes
Secondary	National Institutes of Health Stroke Scale (NIHSS)		4 weeks	No